ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31373 results sorted by trial registration date.
  • Enhanced care and support in early labour (ecsel) trial

    This study aims to examine whether extra support from a midwife in early labour, before arrival at hospital, can safely reduce the number of women who give birth by caesarean. Women who agree to take part are allocated by chance to receiving this extra care, or to the usual support provided at the hospital. Once they arrive at hospital, care is provided according to the usual hospital practices.

  • Videolaryngoscopy for Intubation in Neonates: an Evaluation– a randomized controlled study (The Vine study)

    This study is looking at methods used to intubate (insert a breathing tube that connects to a ventilator) sick infants. The standard method, which has been used internationally for many years, involves the doctor first inserting a laryngoscope into the infant’s mouth. This is an L-shaped device with a light at the tip. When it is manipulated correctly, it moves the infant’s tongue and jaw allowing a view of the infant’s airway. The doctor can then insert the breathing tube through the voice-box into the airway. This is a difficult procedure for doctors to learn and more than one attempt is often required to insert the breathing tube correctly. A more senior supervising doctor is usually present to assist during the procedure but is limited by the fact that he/she cannot see in the infant’s mouth. The devise being examined in this study is a videolaryngoscope. This is structurally the same as a traditional laryngoscope but displays real time images on to a nearby monitor. This essentially means that the assisting doctor can now see what the intubating doctor sees and can therefore potentially offer improved guidance and assistance. This is a randomised controlled trial and any infant at the Royal Women’s Hospital, Melbourne, who requires intubation, is eligible for inclusion. If the infant is very sick and needs urgent intubation, they are excluded. All intubations in the study will be performed by neonatal registrars, who are junior doctors in training. The enrolled infants will be allocated randomly into the intervention group or the control group. In the intervention group, the registrar will attempt to intubate the infant using the videolaryngoscope and standard breathing tubes. A supervising doctor will be present and view the videolaryngoscope screen. They will offer instruction to the registrar based on the images they see. In the control group, the registrar will attempt to intubate using the videolaryngoscope and standard breathing tubes. However this time, the monitor will remain covered during the intubation attempt. The registrar will still be offered verbal guidance, as would be standard current practice. In both groups it will be recorded if the first attempt resulted in correct placement of the breathing tube. The main result of the study will be a comparison of the rate of correct tube placement between the two groups.

  • The effect of anterior cruciate ligament injury on skeletal muscle function, contractile proteins and inflammation

    Damage to the Anterior cruciate ligament (ACL), a ligament vital for the stability of the knee joint, affects the ability to perform daily activities and physical exercise. The reduced physical activity caused by knee injury can cause changes in the muscle of the leg, causing decreased muscle strength, size and endurance. This study proposes to test the effect of ACL injury (knee injury) on muscle on a microscopic or molecular level, and investigate how such molecular changes in the muscle can affect knee function. A second aim of the study is to investigate the role of inflammation in the knee joint and how it affects leg strength and physical activity levels. This will be achieved by measuring strength, balance, physical activity levels, and muscle samples in patients undergoing ACL reconstructive surgery compared to a matched control group. It is hypothesized that after acute ACL trauma, functional changes in quality of life and muscle function of the injured limb will be associated with adverse changes in knee extensor muscle contractility on a biochemical level.

  • A study of blood vessel reactivity in liver cirrhosis

    The purpose of this project is to improve our understanding of the mechanism by which patients with advanced Liver disease (or cirrhosis) develop common complications related to abnormalities in blood flow. These complications include bleeding from the gut (variceal bleeding), behavioural changes (hepatic encephalopathy) and fluid build-up in the abdomen (ascites). Events such as these have a significant impact on patients affected by cirrhosis leading to a deterioration in their quality of life, frequent hospital admissions and in some cases, death. The mechanism behind this abnormal blood flow that occurs in cirrhosis is so far not fully understood. Recently studies performed by our group on animal blood vessels strongly indicate that these problems arise in cirrhosis due to abnormal responses to a hormone, Angiotensin 1-7 (Ang 1-7). As of yet, studies of human blood vessel reactivity to Ang 1-7 in cirrhosis have not been carried out. We propose to perform detailed analysis of blood vessel reactivity to Ang 1-7 on approximately 16 Austin and Alfred Health patients using a technique called Forearm Plethysmography (FP). The FP study will involve insertion of a small tube (cannula) into an artery of the forearm through which Ang 1-7 and other agents will be delivered. After drugs to be studied have been administered changes in blood vessel reactivity will be assessed using a specially designed band around the forearm which records and measures changes in it’s size. Half of the patients involved in the study will have cirrhosis and will be listed for Liver transplantation. The other half will be patients not affected by Liver disease (‘the control group’). Patients with cirrhosis will be asked to return for a repeat study after they have undergone liver transplantation. This study will help us to establish the role of Ang 1-7 in human cirrhosis and may lead the way to further research and the development of available therapies. Also in this study we will evaluate a novel medical device called EndoPAT. EndoPAT is a non-invasive device used to assess the reactivity of blood vessels by applying sensor pads to the tips of the fingers. It's use has not yet been studied in a cirrhotic population where it has the potential to be used as a screening tool to predict complications of cirrhosis.

  • 'OCD? Not Me! Curtin On-line Obsessive-Compulsive Disorder Treatment for Young People

    The overall goal of this project is to develop an online CBT based self-help program for children and adolescents with OCD which incorporates families and carers in the treatment plan. This will fill the current gap between psychoeducation only and high intensity face-to-face assessment and therapy. Consistent with the proposed actions of the research plan, this program will improve the support given to and build the resilience of families and carers of young people with OCD, expand community based youth mental health services, and provide an accessible and targeted treatment to those young people who do not require immediate high intensity intervention.

  • A comparison of alcohol delamination and phototherapeutic keratectomy for the treatment of recurrent erosion syndrome.

    To compare two different treatment methods of reducing pain and recurrent episodes in individuals with recurrent corneal erosion syndrome, a syndrome characterised by pain, watering and light sensitivity due to episisodic loosening of the surface cells of the eye. The two methods are laser treatment and alcohol treatment to the surface of the eye. It is hypothesised that the two methods are comparable in their effect.

  • Facilitating Older-Adults' Resilience: A Pilot study of a Mindfulness Intervention for Chronic Pain

    This proposed pilot study's purpose is to explore the viability of a mindfulness meditation intervention in a sample of older-adults residing in a residential aged-care home who have chronic pain. It is hypothesised that for those older adults in the intervention group, mindfulness meditation will have a beneficial effect and decrease these older-adults scores on measures of pain and depression, while also demonstrating a tendency for increased post-study scores of acceptance and awareness.

  • A randomised controlled trial of acupressure to assist spontaneous labour for women who are pregnant for the first time experiencing post-date pregnancy: A pilot study

    This study aims to determine whether primigravida women who are experiencing post-date pregnancy (41 weeks gestation) are more likely to experience spontaneous onset of labour using specific acupressure points than women receiving usual antenatal care only. The secondary aim is to explore the women’s experience on the care received and being randomised. For women allocated to the acupressure group,information will be collected on their compliance with intervention protocol and satisfaction with the use of acupressure. This study will add to the body of knowledge and has the potential to address the strategies and targets set by NSW Health Policy Directive Towards Normal Birth, by increasing the number of women commencing labour spontanously and reducing the rate of medical interventions (labour induction).

  • A Randomised, Clinical Trial of Corneal Collagen Cross-Linking in Keratoconus

    The technique of collagen cross-linking for keratoconus (a condition leading to thinning and protrusion of the cornea, the front clear window of the eye, leading to a reduction in vision) was introduced in Europe. It involves the use of riboflavin (vitamin B2) and ultraviolet light A, and has been shown in animal studies to strengthen the cornea. This trial was initiated to assess the effectiveness and safety of this treatment in comparison to a second group of participants who have the disease but are not given the cross-linking treatment. It runs over 5 years.

  • Does Arginine supplementation need to be part of routine clinical education for Diabetes Educators in the management of foot ulcers

    Diabetes is a multi-factorial disease, with a multi-disciplinary approach being advocated for diabetes treatment and the prevention of its complications. In Australia, diabetes is the most common cause of lower limb amputation after trauma. Diabetic foot ulcers are responsible for a substantial medical and financial burden on the Australian healthcare system with costs conservatively estimated to be as high as $45,000 per patient. Improved nutritional status and nutrition supplementation accelerate wound healing while inadequate nutrition prolongs wound healing. During wound healing non-essential amino acids, such as L-Arginine, becomes essential as it enhances a number of pathways involved in wound healing, protein metabolism, such as structural protein synthesis and collagen. Aim: To determine whether supplementation with L-Arginine will improve the healing of diabetic foot ulcers in a routine community based client education and management program conducted by medical and allied health professionals. Methods: This study is being designed as a double blinded RCT (treatment group: n=37+7, 4.5g L-arginine; control group n=19+7 placebo) for 12 weeks. Power calculations indicate 70 patients are required to provide adequate statistical power including anticipated attrition rate. The study will be conducted in a routine community based client education and management setting which includes health professionals (medical, podiatry, dietetic, diabetes educators) as part of a multi-disciplinary approach and holistic care for the client

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